The present invention relates to surgical equipment, and more particularly, to a device for maintaining intravascular access devices, such as needles, tubes, and catheters in fixed position while administering intravascular therapy, wherein the risk of accidental dislodgement of the intravascular access device during the therapy is minimized substantially.
More particularly, the present invention relates to a structure for immovably maintaining an intrasvascular access device in fixed position on a limb of a patient, with the structure including a needle immobilizing unit and a tube locking member securing a connecting tube of the intra-vascular access device in fixed position to the needle member. The needle immobilizing unit includes a substantially transparent shield covering the needle member that allows immediate visual recognition of any dislodgement of the intra-vascular access device whenever such may occur.
Further, the present invention relates to a hemodialysis and vascular splint which conveniently and comfortably supports intravascular access devices at a patient""s extremity for an extended period of time which is required by certain intravascular therapies including hemodialysis. More particularly, the present invention relates to a splint which comprises two independent members assemblable and easily separable each from the other so that each may be used independently or in combination dependent upon the specific procedure.
The present invention also relates to a splint for supporting intravascular device(s) in fixed position which includes one or two separable splint members where each is affixed to a respective body part by at least one strap which is slidable along the splint member and whose length is adjustable. The splint also maintains an intravascular access device (the needle member and the connecting tube) thereon in the locked position thereby preventing unwanted dislodgement of the intravascular access device during therapy.
In the field of surgery, intravascular access devices are widely used for many purposes. For example, the vascular access can be venous when fluids, such as medicine or supporting fluids, are desired to be given to a patient undergoing a surgical procedure. In medical emergencies, intravenous access may be needed to administer fluids, antibiotics, and other medication especially when the patient cannot ingest such through the mouth.
Another type of vascular access, arterial access, is needed to monitor the patient""s blood gases and may be used for monitoring his or her vital signs. Patients on hemodialysis may need intravascular access two to three times each week for a period of three hours or longer.
If a needle is dislodged in any of these procedures, and the dislodgement goes unnoticed, severe bleeding may occur. In such instances, the patient may lose a large amount of blood before the medical personnel recognizes the emergency situation. In some cases where the patient is heparinized, i.e., blood is prevented from clotting, the patient may bleed to death, unless the bleeding is recognized and stopped. In hemodialysis, the blood loss in such emergency situations could be as high as several hundred millimeters each minute.
In order to impede separation of the connecting tube from a needle of the intravascular access device, traditionally, strips of tape are applied to a patient""s limb which secures the connecting tube and the needle in the proper position on the patient""s body. Disadvantageously, this technique abrades hair and skin of the patient in the contact areas and in some instances, may cause serious unwanted skin reaction.
Several attempts have been made in the art to develop a technique which would prevent the vascular bleeding when intravascular access is desired. For example, U.S. Pat. No. 5,601,597 describes the combination radial artery occluder and wrist splint used to simultaneously immobilize the wrist joint and prevent blood flow through a puncture wound or incision in the radial artery following an invasive medical procedure, such as catheterization. The device generally includes three components: a wrist splint that extends along the distal end of the patient""s forearm and the back of the wrist and hand; an adjustable pressure strap attached to the splint that extends around the distal end of the forearm; and an adjustable securing strap attached to the splint that extends around the palm of the patient""s hand. The pressure strap includes a pressure pad that is selectively positioned to occlude blood flow through only the radial artery, while allowing blood flow through the ulnar artery. During use, the securing strap is tightened around the palm of the hand to help immobilize the wrist joint. The adjustable pressure strap is slowly tightened onto the forearm or wrist over the wound until radial artery blood flow has stopped at the wound. Although intended for stopping blood from punctured arteries, this device is not contemplated for use during the intravascular access procedure, and therefore, no means are envisioned for securing an intravascular access device to the patient""s limb.
A prior art splint for use with intravenous lines is described in U.S. Pat. Nos. 4,425,913 and 4,502,477. The splint supports the hand, wrist, and at least a portion of the forearm of a patient during the time, when the patient is connected to a lifeline, e.g., intravenous tube. The splint incorporates a substantially rigid molded body defining several shapes. A dome is provided for mating engagement with the palm of the hand and a tranversely arcuate curved channel extends away from the dome to receive the wrist and a portion of the forearm. The molded body defines securing means for the lifeline, as in the form of rolled or beaded edges of the body which also add strength and rigidity. The molded body is to be physically attached to a patient by the straps, with a hand strap extending somewhat diagonally in relation to the dome, while a pair of forearm straps extend laterally from the opposed side of the molded body. The length of the straps is adjusted by a Velcro type contact fastening member. In use, after the splint is positioned onto the patient and the molded body is secured in place with the contact straps, the intravenous lifeline is connected with the tube anchored in a channel extending along the edges of the molded body. As is readily understandable for those skilled in the art, this splint is intended merely as a support to immobilize the forearm and hand of the patient during intravenous therapy and also as a support for a lifeline, i.e., connecting tube through which liquid is supplied to a needle or a catheter. Disadvantageously, no means are contemplated which would secure the connecting tube to the needle introduced into the blood vessel.
Therefore, in such prior art, a dangerous, undesirable disconnection of the lifeline from the needle may occur. It is a further drawback of the splint described in the previous paragraphs that it is not designed for use as a support for a needle or catheter inserted into the blood vessel of a limb. As a further disadvantage, it may be recognized that different sizes of the splint are generally desirable to accommodate the physical dimensions of different patients, as well as different dimensional needs for the right and the left limbs of the same patient which may require different splints.
A fluid administration splint is also described in U.S. Pat. No. 4,505,270. This splint is intended as a shield for a catheter taped to the leg of an animal. The splint includes an extendable splint member hinged to an extendable cover for accommodating different lengths of a leg, and a latch for securing the splint assembly to a door of a cage containing the animal receiving intravenous fluid. Similar to the splint described in previous paragraphs, the fluid administration splint shown in this prior art is merely a support to immobilize the limb during intravenous therapy.
As it is readily appreciated by those skilled in the art, none of the splints discussed in the previous paragraphs contemplates any means which would secure the needle or a catheter, immovably with respect to its connecting tube during the intravascular access therapy. Further, none of them are intended for use with the arm part, forearm part, and/or the hand of the patient, in combination or individually.
Therefore, despite numerous attempts in the field of surgery to provide means or technique which would reliably secure the intravascular access device in position, no satisfactory technique has been developed to date prior to the subject system.
It is an object of the present invention to provide a device for supporting an intravascular access device in position during a therapy while the needle of the intravascular access device is introduced into the blood vessel, whereby the needle is prevented from being dislodged from its position and from being separated from a connecting tube.
It is a further object of the present invention to provide a device for supporting the intravascular access device in position at any portion of the upper limb of a patient undergoing a therapy, i.e., hand, arm part, or forearm part of the upper limb.
It is still a further object of the present invention to provide a device for supporting the intravascular access device in position on the upper limb during an intravascular procedure, which is substantially universal for any size or gender of patient.
It is still a further object of the present invention to provide a splint for supporting an intravascular access device in fixed position which includes one or two separable independent splint members each of which is securable to a respective part of the upper limb of the patient and which further can be used independently or in combination with each other, thus providing a flexible and universal splint.
It is still another object of the present invention to provide a splint for supporting the intravascular access device in position on the upper limb of the patient in which each splint member is secured to a respective part of the upper limb of the patient by at least one strap slidable along the longitudinal axis of the splint member to occupy the precise position proximal to the point of intravascular access. The length of each strap is adjustable and each strap carries a needle immobilizing unit with a tube locking member for securing the connecting tube to the needle. In this manner, the connecting tube cannot be dislodged from the needle inserted into the blood vessel.
It is yet a further object of the present invention to provide a splint for supporting an intravascular access device in fixed position which includes a needle immobilizing unit displaceable along and around the respective part of the upper limb of the patient which is positioned in close proximity to the point of the needle access into the blood vessel. The access device secures the needle in place and locks the connecting tube to the needle for the period of time needed to perform a surgical procedure or therapy.
It is another object of the present invention to provide a splint for supporting the intravascular access device in position on the upper limb of the patient, wherein each splint member is secured to a respective part of the upper limb of the patient by individual straps, the length of each is individually adjustable.
It is yet another object of the present invention to provide a splint for supporting the intravascular access device in position, where the arm and forearm splint members (or the forearm and hand splint members) are pivotally connected to each other and where an elbow joint between the arm and forearm splint members (or a wrist joint between the forearm and hand splint members) can lock these members angled to each other at varying angles, i.e., 90xc2x0, 180xc2x0, 220xc2x0, etc., for further convenience and comfort of the patient.
In accordance with the present invention, an apparatus for maintaining intravascular access device in position at an access point on a limb of a patient includes a needle immobilizing unit and a tube locking member carried on a supporting structure which supports the needle immobilizing unit in close proximity to the access point on the limb of the patient.
During the therapy, the needle immobilizing unit engages the needle member and locks the same in place, thereby preventing the needle member from dislodgement from the blood vessel. The tube locking member locks the connecting tube of the intravascular access device in place, thereby preventing the connecting tube from being separated from the needle member.
Preferably, the supporting structure constitutes a strap member encircling a respective part (arm, forearm, or hand) of the limb of the patient. The length of the strap member is adjustable for substantially matching a circumference of the respective portion of the limb of the patient.
The needle immobilizing unit includes a transparent shield secured to the strap member which has a semi-cylindrical central portion extending longitudinally along the substantially transparent shield and a pair of fans extending symmetrically from the center portion of the transparent shield. The fans engage the skin on the limb of the patient during the therapy while the central portion of the transparent shield receives the intravascular access device therewithin. It is important that locking wings extend at the proximal ends of the fans to engage the needle wings of the intravascular access device, thereby preventing the needle member from being dislodged from the blood vessel.
The substantially transparent shield allows the medical personnel to observe any bleedings which may occur at the access point on the limb of the patient during the therapy and thus to allow necessary measures to be taken.
Preferably, a plurality of holes are disposed across the surface of the transparent shield to permit ventilation.
The tube locking member is affixed on the strap member a predetermined length from the needle immobilizing unit. The tube locking unit has either a clip type structure or a tube housing unit which has a bottom portion and a top portion pivotally joined each to the other at one end thereof and having latching mechanism at another end thereof. When the top and bottom portions of the tube housing unit are latched, a tube receiving channel is formed therein extending laterally through the tube housing unit, so that the connecting tube is impeded from decoupling from the needle member of the intravascular access device. Preferably, fine teeth are provided within the tube receiving channel to fixedly hold the connecting tube.
Optionally, the tube housing unit may have two tube receiving channels of differing cross-sectional dimensions for receiving connecting tubes of different sizes.
From another aspect, the present invention is a splint assembly which comprises two independent splint members pivotally coupled to each other and easily separable from each other. The splint members can be used independently or in joint arrangement. One splint member may be secured to the forearm part of the limb of the patient while the second splint member may be secured either to the arm part of the limb of the patient or to the hand of the patient.
Each splint member has slots extending longitudinally along the length thereof, and one or more straps sliding along the longitudinal slots. Each strap has an adjusting mechanism so that the length of the strap can be adjusted to correspond exactly to the circumference of the limb of the patient.
There are two basic kinds of straps used with the splint assembly of the present invention. One type, which is a supporting strap, serves to support the splint member on the respective part of the limb of the patient. Another type of the strap carries a needle immobilizing unit and tube locking member thereon, and serves the two fold purpose of immobilizing the intravascular access device in position and simultaneously supporting the splint member at the respective part of the limb of the patient.
At the joint between two splint members a joint assembly is provided which releasably pivotally couples the splint members to each other. The joint assembly includes a latching mechanism locking the splint members in a desired angled relationship therebetween. For example, the splint members may be locked at 90xc2x0 at the elbow joint when used for the arm/forearm parts of the limb of the patient. When used for the forearm/hand parts of the limb of the patient, the splint members can be locked at 200xc2x0 with respect to each other.
Another aspect of the present invention directs itself to a method for maintaining an intravascular access device in position at an access point on a limb of a patient during therapy. According to this method, a strap member carrying a needle immobilizing unit and a tube locking member is positioned at a respective part of the limb of the patient to encircle this respective part adjacent to the access point of the blood vessel.
The length of the strap member is adjusted to match the circumference of the part of the limb of the patient. The needle member of the intravascular access device is then locked in position while being introduced into the blood vessel by means of the needle immobilizing unit which has locking wings engaged with the needle wings. After this, the connecting tube is locked within the tube locking unit carried on the strap member.
Optionally, one or more splint members can be secured to the limb of the patient by the strap member carrying the needle immobilizing unit and the tube locking member.
If two splint members are used, before being attached to the limb of the patient, the splint members are coupled each to the other at respective ends thereof.
Preferably, the method further includes the steps of latching the first and second splint members in a desired angular relationship which optimizes comfortability of the patient undergoing the therapy.